Status:
COMPLETED
Hormone Responses During Hypoglycemia and the Accuracy of Continuous Glucose Monitors
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
3-17 years
Brief Summary
The primary objective of this study will be to compare the glucose level at which counter-regulatory hormone responses occur during hypoglycemia in young children with diabetes, with the glucose level...
Detailed Description
The present study is being undertaken to compare counterregulatory hormone responses to a mild and gradual reduction in plasma glucose in young children with T1DM versus responses in adolescents. The ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Age 3.0 to \<7.0 years or 12.0 to \<18.0 years
- Weight \>12.8 kg (28.2 lbs) for reinfusion centers (centers that employ reinfusion of blood drawn to clear the dead space in intravenous catheters) and \>17.4 kg (38.3 lbs) for discard centers (centers that discard the blood drawn to clear the dead space)
- Hemoglobin A1c \<10.0%
- Subject currently uses an insulin pump
- Parent/guardian and subject understand the study protocol and agree to comply with it
- Informed Consent Form signed by the parent/guardian and Child Assent Form signed by the subject
Exclusion
- The presence of a significant medical disorder or use of any medication that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
- Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
- A severe hypoglycemic event resulting in seizure or loss of consciousness in the last month
- Use of systemic or inhaled corticosteroids in the last month
- Cystic fibrosis
Key Trial Info
Start Date :
December 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00607139
Start Date
December 1 2006
End Date
April 1 2007
Last Update
September 5 2016
Active Locations (6)
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1
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, United States, 94305
2
Barbara Davis Center for Childhood Diabetes, University of Colorado
Aurora, Colorado, United States, 80010
3
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, United States, 06520
4
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207